Tests a diet to treat active ulcerative colitis in adults
Tests a sustainable diet as a way to change gut bacteria in ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Diet Intervention Treatment for Active Ulcerative Colitis
Key facts
- Where
- Toronto, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04121806, who can take part
Where in Canada
- Mount Sinai HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mount Sinai Hospital, Canada
- Trial code
- NCT04121806
- Record updated
- 29 September 2025
- Original description
The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.Read full original descriptionShow less
Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.
Inclusion: • Females and Males between the ages of 18 - 75 years of age at the time of enrolment; Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria; Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment; Must have had > 10cm involvement at some point in their disease history; FCP>250 or active endo within 6 months; If a smoker, must not change smoking habits (frequency) during the course of the study; If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study.
Exclusion: • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment; Pregnant or lactating females; Allergy or intolerance to key or a great number food components of the study diet; Current NSAID use; Diagnosed with PSC; Using topical therapies or suppositories; Antibiotic use within 4 weeks of the study enrollment or during the study; Confirmed C. difficile infection within 3 months of recruitment; Diagnosis of primary PSC; Currently using topical therapies or suppositories; History of dysplasia or colorectal neoplasia.